Dementia, MildNCT06292741
Autonomic Involvement in Patient With Cognitive Decline
A study testing Sudoscan in people with Dementia, Mild and Dementia of Alzheimer Type, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dementia, Mild, Dementia of Alzheimer Type
- What is being tested?
- Sudoscan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and females between 50 and 85 years
- cognitive decline (dementia, lewy's body dementia, Parkinson dementia, Alzheimer dementia)
- mild cognitive decline ( lewy's body MCI, Parkinson MCI and Alzheimer MCI)
- Ability to assume the upright position
Who cannot join
- diabetes mellitus
- eye problems
- severe cognitive decline
- heart disease
- peripheral neuropathy
- language barrier
- oncological disease
- medical pathologies associated with cognitive deficits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS
Rome, Lazio, 00168
Camillo Marra, MD, 0630154333, camillo.marra@policlinicogemelli.it
About this study
Official title: Evaluation of the Prevalence of Autonomic Nervous System Involvement in Patients With Cognitive Impairment by a Non-invasive Combined Study of Dysautonomia
Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline
- Conditions
- Dementia, Mild, Dementia of Alzheimer Type
- Being tested
- Sudoscan
- Medical subject headings
- Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SudoscanDevice
Also called automated pupillometry NPI-200
recording of sudomotor function and pupillary reactivity
| Study group | Role | What they receive |
|---|---|---|
| cognitive decline | Experimental | comparison of autonomic parameters among subjects with different forms of cognitive decline Receives: Device: Sudoscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia
evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia
Measured: baseline through study completion, an average of 3 year
Secondary outcomes (2)
correlation between the extent of autonomic involvement and the severity of cognitive decline
correlation between the extent of autonomic involvement (pupillary dilatation velocity) and the severity of cognitive decline (MMSE score)
Measured: baseline through study completion, an average of 3 year
evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction.
evaluation of the type of cognitive disorder between subjects with and without autonomic dysfunction
Measured: baseline through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start11 Jan 2023
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camillo Marra, MD, Principal investigator, Memory clinic- Policlinico Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292741
- Sponsor's protocol ID
- 4956
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2023
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Autonomic Nervous System Involvement in Patients With Cognitive Impairment by a Non-invasive Combined Study of Dysautonomia
- ClinicalTrials.gov ID
- NCT06292741
- Acronym / sponsor ID
- 4956
- Conditions
- Dementia, Mild, Dementia of Alzheimer Type
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cognitive decline | Experimental | Device: Sudoscancomparison of autonomic parameters among subjects with different forms of cognitive decline |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and females between 50 and 85 years
- cognitive decline (dementia, lewy's body dementia, Parkinson dementia, Alzheimer dementia)
- mild cognitive decline ( lewy's body MCI, Parkinson MCI and Alzheimer MCI)
- Ability to assume the upright position
Key exclusion criteria (8 listed)
- diabetes mellitus
- eye problems
- severe cognitive decline
- heart disease
- peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SudoscanAlso: automated pupillometry NPI-200recording of sudomotor function and pupillary reactivity | Device | cognitive decline |
Primary outcome
evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia
Time frame: baseline through study completion, an average of 3 year
evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia
2 secondary outcomes
correlation between the extent of autonomic involvement and the severity of cognitive decline
Time frame: baseline through study completion, an average of 3 year
evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction.
Time frame: baseline through study completion, an average of 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camillo Marra, MD principal investigator
Memory clinic- Policlinico Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudoscan in people with Dementia, Mild and Dementia of Alzheimer Type, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camillo Marra, MD (0630154333, camillo.marra@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia (time frame: baseline through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.